JP2021504321A5 - - Google Patents

Claims (14)

Pharmaceutical composition containing:
a. An antibody or antigen-binding fragment thereof from about 80 mg / ml to about 200 mg / ml having a heavy chain variable region containing SEQ ID NO: 1 and a light chain variable region containing SEQ ID NO: 2.
b. About 20 mM to about 100 mM settate ;
c. About 140 mM to about 350 mM glycine;
d. About 0.01% to about 0.07% (w / v) of polysorbate 80 and;
It has a pH of about 4.6 to about 5.5. The pharmaceutical composition according to claim 1, which comprises from about 120 mg / ml to about 185 mg / ml of an antibody or antigen-binding fragment thereof, preferably about 160 mg / mL. The pharmaceutical composition according to claim 1 or 2 , wherein the composition comprises from about 160 mM to about 300 mM glycine. The pharmaceutical composition according to any one of claims 1 to 3 , wherein the composition comprises an acetate of about 40 mM to about 90 mM. The pharmaceutical composition according to any one of claims 1 to 4 , wherein the antibody or an antigen-binding fragment thereof specifically binds to human IL-17A and human IL17F. The pharmaceutical composition according to any one of claims 1 to 5, wherein the composition comprises:
a. About 120 mg / mL to about 185 mg / mL antibody or antigen-binding fragment thereof;
b. About 40 mM to about 90 mM settate;
c. Approximately 160 mM to approximately 300 mM glycine;
d. About 0.01% to about 0.07% (w / v) polysorbate 80,
Here, the composition has a pH of about 4.6 to about 5.5. A method for preparing a pharmaceutical composition according to any one of claims 1 to 6.
a. An antibody or antigen-binding fragment thereof having a heavy chain variable region containing SEQ ID NO: 1 and a light chain variable region containing SEQ ID NO: 2 and having an antibody of about 40 mg / ml to about 50 mg / ml or an antigen-binding fragment thereof, has a pH of about 4.6 to about 5.5. To prepare a low-concentration formulation by combining with a buffer solution containing glycine and antigen in.
b. The step of preparing a high-concentration preparation by concentrating the antibody of the low-concentration preparation obtained in a) or an antigen-binding fragment thereof to a concentration of about 160 mg / ml to about 180 mg / ml;
c. The step of adding polysorbate 80 to the high-concentration preparation obtained in b);
d. The method described above, optionally comprising adjusting the concentration of the antibody or antigen-binding fragment thereof with a buffer containing glycine and acetate prior to step c). The buffer contains about 20 mM to about 100 mM acetate, preferably about 40 mM to about 90 mM and about 140 mM to about 350 mM glycine, with polysorbate 80 at step c) of about 0.01 to about 0.07% (w). The method of claim 7 , wherein the method is added at the final concentration of / v). The pharmaceutical composition obtained according to claim 7 or 8. The pharmaceutical composition according to claim 9 , wherein the pH of the composition is about 4.6 to about 5.5. A container containing the pharmaceutical composition according to any one of claims 1 to 6 , 9 or 10. The pharmaceutical composition according to any one of claims 1 to 6 , 9 or 10 for use in treatment. Arthritis, rheumatoid arthritis, psoriatic arthritis, psoriatic arthritis, systemic onset juvenile idiopathic arthritis (JIA), systemic lupus erythematosus (SLE), asthma, chronic obstructive airway disease, chronic obstructive pulmonary disease, atopic dermatitis, strong Treatment of pathological disorders selected from the group consisting of scleroderma, systemic sclerosis, pulmonary fibrosis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, axial lupus erythematosus, and other spondyloarthropathies. Or the pharmaceutical composition according to any one of claims 1 to 6 , 9 or 10 for use in prevention. Arthritis, rheumatoid arthritis, psoriatic arthritis, psoriatic arthritis, systemic onset juvenile idiopathic arthritis (JIA), systemic lupus erythematosus (SLE), asthma, chronic obstructive airway disease, chronic obstructive pulmonary disease, atopic dermatitis, scleroderma Treatment of pathological disorders selected from the group consisting of scleroderma, systemic sclerosis, pulmonary fibrosis, Crohn's disease, ulcerative colitis, tonic spondylitis, axial lupus erythematosus, and other spondyloarthropathies. Or the use of the pharmaceutical composition according to any one of claims 1 to 6 , 9 or 10 in the manufacture of a drug for prevention.